Public recall detail

Vitek 2 Software Version 9.01/9.02

2024-07-12

medium
Recall Safety notice
Quick summary

Quick summary: Vitek 2 Software Version 9.01/9.02. Date: 2024-07-12.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Vitek 2 Software Version 9.01/9.02. Date: 2024-07-12.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBiomerieux, Inc.
ProductVitek 2 Software Version 9.01/9.02
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75811

Affected products

ProductVitek 2 System - Vitek 2 Instrument
LotSoftware Version 9.01/9.02
Model27225 27220
Serial numberSoftware Version 9.01/9.02
DescriptionVitek 2 System - Vitek 2 Instrument
ProductVitek 2 System - Vitek 2 Xl Instrument
LotSoftware Version 9.01/9.02
Model27227 27222
Serial numberSoftware Version 9.01/9.02
DescriptionVitek 2 System - Vitek 2 Xl Instrument
ProductVitek 2 Compact 15
LotSoftware Version 9.01/9.02
Model27415
Serial numberSoftware Version 9.01/9.02
DescriptionVitek 2 Compact 15
ProductVitek 2 Compact 60 System - Instrument
LotSoftware Version 9.01/9.02
Model27560
Serial numberSoftware Version 9.01/9.02
DescriptionVitek 2 Compact 60 System - Instrument
ProductVitek 2 Compact 30 System - Instrument
LotSoftware Version 9.01/9.02
Model27530
Serial numberSoftware Version 9.01/9.02
DescriptionVitek 2 Compact 30 System - Instrument

Issue

Biomerieux has become aware that when using the Firefox web browser to access the Vitek® 2 software versions 9.01-9.02 and editing the accession ID on an isolate, or a batch of isolates, an anomaly can occur. The Vitek® 2 software version are KIT, UPDT VTK2 09.01/ 09.02 (clinical - ref. 423487) and KIT, UPDT VTK2 9.01/9.02 (industry - ref.423585). Recall start date: June 28, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Microbiology
CompaniesBiomerieux, Inc. 100 Rodolphe Street, Durham, North Carolina, United States, 27712
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75811
Background{}
CompaniesBiomerieux, Inc. 100 Rodolphe Street, Durham, North Carolina, United States, 27712
AudiencesHealthcare Industry
Source updated2024-07-12

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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